I've had three distinct careers: biomedical scientist; FDA drug regulator; and scholar at the Hoover Institution, a think-tank at Stanford University. During the first of these, I worked on various aspects of gene expression and regulation in viruses and mammalian cells. I was the co-discoverer of a critical enzyme in the influenza (flu) virus. While at the FDA, I was the medical reviewer for the first genetically engineered drugs and thus instrumental in the rapid licensing of human insulin and human growth hormone. Thereafter, I was a special assistant to the FDA commissioner and the founding director of the FDA's Office of Biotechnology. Since coming to the Hoover Institution, I have become well known for both contributions to peer-reviewed scholarly journals and for articles and books that make science, medicine, and technology accessible to non-experts. I have written four books and about 2,000 articles. I appear regularly on various nationally syndicated radio programs. My most frequent topics include genetic engineering, pharmaceutical development, and the debunking of various manifestions of junk science.

Another Obama Cabinet Member Falls Short

President Obama’s mounting scandals and plummeting approval ratings illustrate the old maxim that life is tough, and it’s even tougher if you’re stupid—as so many administration officials have shown themselves to be.

We may be about to see a further demonstration of that principle in the ongoing EU-U.S. Transatlantic Trade and Investment Partnership (TTIP) talks. If successful, they would culminate in the world’s largest free-trade pact.

But agricultural issues offer some of the most difficult stumbling blocks to its completion. Secretary of Agriculture Tom Vilsack spoke publicly on June 17 about the need to eliminate the “non-scientific barriers” that prevent U.S. farmers from selling many genetically engineered crops in Europe. “Science is a common language . . . ”, he told a media briefing in Brussels. “We will be working towards making sure that whatever agreements are reached, they are consistent with sound science.”

Those are the right sentiments. Unfortunately, Tom Vilsack advocating sound science is about as credible as National Security Adviser Susan Rice lecturing on truthfulness or Vice-President Joe Biden talking about almost anything. The regulatory approach of USDA’s Animal and Plant Inspection Service is anything but scientific, and Vilsack, who has headed the department for more than five years, has actually made things worse. (Sound familiar? Think of Eric Shinseki and his “leadership” of the Department of Veterans Affairs, Hillary Clinton and John Kerry at State, Kathleen Sebelius at HHS, Chuck Hagel at Defense and Lisa Jackson at EPA.)

USDA’s illogical, arbitrary, overly complex regulation of genetically engineered crops is a historical fluke; it should never have come to pass.

In 1986 the White House Office of Science and Technology Policy published a policy statement on the regulation of biotechnology that got it right by focusing oversight and regulatory triggers on the risk-related characteristics of products, such as plants’ weediness or toxicity. That approach specifically and emphatically rejected regulation based on the particular process used for genetic modification, which, in fact, has been performed for centuries by a continuum of techniques.

In 1992, a second policy statement from the federal government reaffirmed the overarching principle for biotechnology regulation: The degree and intrusiveness of oversight “should be based on the risk posed by the introduction and should not turn on the fact that an organism has been modified by a particular process or technique.” [OSTP (Office of Science and Technology Policy). 1992. Exercise of federal oversight within scope of statutory authority: Planned introductions of biotechnology products into the environment. Federal Register 57:6753–6762.]

Thus, there has been a broad consensus in the scientific community—reflected in early statements of federal government policy—that the newest techniques of genetic modification are essentially an extension, or refinement, of older, less precise and less predictable ones and that oversight should focus on the characteristics of products, not on the processes or technologies that produced them. USDA’s Animal and Plant Health Inspection Service has long regulated the importation and interstate movement of organisms (plants, bacteria, fungi, viruses, etc.) that are “plant pests,” as defined in an inclusive list.

This is essentially a “thumbs up or thumbs down” approach: A plant that an investigator might wish to introduce into the field was either on the inclusive, prohibited list of plants pests—and therefore required a permit—or it was exempt. This straightforward approach is risk-based, in that the organisms required to undergo case-by-case governmental review are an enhanced-risk group—organisms that can injure or damage plants—compared to organisms not considered to be plant pests.

However, intent on building a regulatory empire, USDA spawned a kind of evil twin of this sensible, risk-based regulation—a massive, superfluous, obstructive USDA bureaucracy called Biotechnology Regulatory Services.

To give life to this monstrous bureaucracy, USDA had to torture the original concept of a plant pest as something known to be harmful and introduced a new, jury-rigged category: a “regulated article,” defined in a way that captures virtually every genetically engineered plant for case by-case review, regardless of its potential risk.

In order to perform a field trial with a regulated article, a researcher must apply to USDA and submit extensive paperwork before, during and after the field trial. After conducting field trials for a number of years at many sites, the developer then must submit a voluminous dossier of data and request “deregulation” by USDA, which is equivalent to approval for unconditional cultivation and commercialization.

These requirements make genetically engineered plants extraordinarily expensive to develop and test—which is the reason that up to now, commercialization has been limited primarily to vast-scale commodity crops.

Moreover, the fact that USDA’s regulatory policy makes “deregulation” a “major action” triggers certain required assessments under the National Environmental Policy Act, which has provided an opportunity for activists to enlist the courts in obstructing the deregulation of various genetically engineered plant varieties. This has caused Vilsack’s department to become embroiled in a series of legal challenges to its approvals, which could have been avoided had USDA crafted its policies more judiciously.

USDA’s discriminatory treatment of genetically engineered plants—most of which have been modified for enhanced pest-, disease- or herbicide-resistance—makes no sense. Genetic modification of one sort or another has long been performed with a seamless continuum of techniques, from crude, older ones to newer, more precise and predictable ones. One important genetic-modification technique, “wide cross” hybridization, has been performed by plant breeders since the 1930s. With this method, breeders move large numbers of “alien” genes from one species or one genus to another in order to create plant varieties that cannot and do not exist in nature. Common commercial crops derived from wide crosses include tomato, potato, sweet potato, oat, rice, wheat, corn, and pumpkin. (These are ubiquitous; they include the varieties found at farmers’ markets and the overpriced organic stuff at Whole Foods.)

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